(100 days)
Not Found
No
The description focuses on standard physiological measurement techniques and computer control for data acquisition and calculation, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a measurement system for arterial blood flow, primarily for research studies, and not for treating or diagnosing a condition.
No
The device is described as a "Blood Flow Measuring system" intended for "measurement of arterial blood flow by means of venous occlusion plethysmography" primarily in "research studies". While it measures a physiological parameter, its stated purpose is measurement for research, not for diagnosing a specific condition or disease in a clinical setting.
No
The device description explicitly states that the Al6 Blood Flow Measuring system measures blood flow using principles of venous occlusion plethysmography, which involves inflating a blood pressure cuff and measuring limb volume changes with plethysmographs. It also mentions cuff inflators and pressure regulators. While a computer program controls these components and calculates results, the system includes significant hardware components (cuffs, plethysmographs, inflators, regulators) that are integral to its function.
Based on the provided information, the Al6 device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is the "measurement of arterial blood flow by means of venous occlusion plethysmography." This is a physiological measurement performed on a living subject, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a system that interacts directly with the patient's limb (inflating a cuff, measuring volume changes). This is characteristic of an in vivo device.
- Lack of Mention of Samples: There is no mention of analyzing blood, tissue, or any other biological sample.
- Focus on Physiological Measurement: The core function is to measure blood flow within the body.
Therefore, the Al6 is a device used for in vivo physiological measurement, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Al6 is the measurement of arterial blood flow by means of venous occlusion plethysmography. The Al6 replaces the predicate instruments which are used primarily in research studies. Applications include studies that relate to protocols that influence limb blood flow through exercise, reactive hyperemia, or the influence of drugs.
The intended use of the Al6 is the measurement of blood flow by means of venous occlusion plethysmography.
Product codes (comma separated list FDA assigned to the subject device)
A16, JOM
Device Description
The Al6 Blood Flow Measuring system measures blood flow in one or two limbs or digits simultaneously using the principles of venous occlusion plethysmography. This involves inflating a blood pressure cuff on the proximal part of the limb to a pressure that exceeds the venous pressure in the limb, but which is less than the arterial pressure. The cuff inflation is done quickly so as to obtain a distinct starting point for the measurement. When the cuff is inflated the limb begins to swell due to the blood flowing into the limb since the normal venous outflow is stopped by the cuff. The resulting change in the volume of the limb is measured by the plethysmographs and the rate of change is equal to the blood flow at the moment of venous occlusion. The Al6 is controlled by a computer program that causes the cuff inflators to inflate, records the plethysmographic volume measurements and calculates the rate of change of volume. By combining the instruments and controlling them with one computer it is possible to make measurements in quick succession and more easily analyze the results.
The accuracy of the strain gauge plethysmographs is the same as that of the predicate device by using the same technology and by employing the same strain gauges. The results of mechanical calibration tests show the Al6 to be equal to the EC6 predicate device.
The accuracy of the pressure requlators is identical to that of the predicate device since the same pressure regulator is used. Although the exact pressure is not very critical in venous occlusion plethysmography, the pressure setting is actually improved in the new device since the pressure is controlled by the computer in a closed-loop system whereas the predicate device is set manually. The requirement is that the pressure in the venous occlusion cuff should be above venous pressure and below arterial pressure, i.e. somewhere between 15 and 100 mmHg. Usually a venous occlusion pressure of 50 to 60 mmHg is chosen in practice. The pressure accuracy of the Al6 is within plus or minus 1 mmHg.
The speed of inflation is controlled by the size of the valves and tubing that connect to the cuff. The tubing used in the Al6 is identical to that used in the E20 predicate device. The valves have a slightly higher Cv than those in the predicate device. The inflation rate measured by inflating a test object is equal to that of the predicate device. Our largest blood pressure cuff can be inflated by the Al6 from 0 to 50 mmHg in less than 300 mSec. In order to show a distinct starting point for a measurement it is desirable to inflate the venous occlusion cuff in less than one heart beat.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs or digits
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests showing equivalence:
Mechanical calibration tests showed the Al6 to be equal to the EC6 predicate device in accuracy of strain gauge plethysmographs.
The pressure accuracy of the Al6 is within plus or minus 1 mmHg, with the pressure controlled by the computer in a closed-loop system.
The inflation rate of the Al6 is equal to that of the predicate device, with the largest blood pressure cuff inflating from 0 to 50 mmHg in less than 300 mSec.
Conclusion: The Al6 is equal to the predicate devices in accuracy and safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K982707, K905367, K973426, K841788/C, K932852
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
0
Supplemental Information for AI6 Blood Flow Measurement System, K023707
K023707
page 1 of 2
510(k) Summary
Date prepared:
December 16, 2002
Submitter's Information
Company Name Establishment Registration Number Street Address City, State, Zip, Country Telephone FAX Contact Person Title E-mail
D. E. Hokanson, Inc 3019130 12840 NE 21st Place Bellevue, WA 98040, USA (425) 882-1689 (425) 881-1636 D. Eugene Hokanson President gene@deh-inc.com
FEB 1 2 2003
Item 6
Trade Name, Common Name, Classification
Trade Name: Hokanson Blood Flow Measuring System Common Name Venous Occlusion Flow Measuring System Classification Name Strain Gauge Plethysmograph System Device Class Class II Product Code Ale
Identification of Predicate Device(s)
The Al6 combines elements and functions of the following devices:
| Device | Manufacturer | 510(k) |
|---|---|---|
| Strain Gauge | ||
| Plethysmograph | Hokanson | K982707 |
| Rapid Cuff Inflator | Hokanson | K905367 |
| ECG Trigger | Hokanson | K973426 |
| Deltran 1 Pressure | ||
| Transducer | Utah Medical | K841788/C |
| NIVP3 Computer Program | Hokanson | K932852 |
Description of the Device
The Al6 Blood Flow Measuring system measures blood flow in one or two limbs or digits simultaneously using the principles of venous occlusion plethysmography. This involves inflating a blood pressure cuff on the proximal part of the limb to a pressure that exceeds the venous pressure in the limb, but which is less than the arterial pressure. The cuff inflation is done quickly so as to obtain a distinct starting point for the measurement. When the cuff is inflated the limb begins to swell due to the blood flowing into the limb since the normal venous outflow is stopped by the cuff. The resulting change in the volume of the limb is measured by the plethysmographs and the rate of change is equal to the blood flow at the moment of venous occlusion. The Al6 is controlled by a computer program that causes the cuff inflators to inflate, records the plethysmographic volume measurements and calculates the rate of change of volume. By combining the instruments and controlling them with one computer it is possible to make measurements in quick succession and more easily analyze the results.
1
510(k) Summary Continued
Intended Use
The intended use of the Al6 is the measurement of arterial blood flow by means of venous occlusion plethysmography. The Al6 replaces the predicate instruments which are used primarily in research studies. Applications include studies that relate to protocols that influence limb blood flow through exercise, reactive hyperemia, or the influence of drugs.
Non-clinical tests showing equivalence.
The accuracy of venous occlusion plethysmographic measurements depends primarily on two things. One is the calibration and accuracy of the strain gauge plethysmograph and the other is the speed and pressure control of the venous occlusion cuffs.
The accuracy of the strain gauge plethysmographs is the same as that of the predicate device by using the same technology and by employing the same strain gauges. The results of mechanical calibration tests show the Al6 to be equal to the EC6 predicate device.
The accuracy of the pressure requlators is identical to that of the predicate device since the same pressure regulator is used. Although the exact pressure is not very critical in venous occlusion plethysmography, the pressure setting is actually improved in the new device since the pressure is controlled by the computer in a closed-loop system whereas the predicate device is set manually. The requirement is that the pressure in the venous occlusion cuff should be above venous pressure and below arterial pressure, i.e. somewhere between 15 and 100 mmHg. Usually a venous occlusion pressure of 50 to 60 mmHg is chosen in practice. The pressure accuracy of the Al6 is within plus or minus 1 mmHg.
The speed of inflation is controlled by the size of the valves and tubing that connect to the cuff. The tubing used in the Al6 is identical to that used in the E20 predicate device. The valves have a slightly higher Cv than those in the predicate device. The inflation rate measured by inflating a test object is equal to that of the predicate device. Our largest blood pressure cuff can be inflated by the Al6 from 0 to 50 mmHg in less than 300 mSec. In order to show a distinct starting point for a measurement it is desirable to inflate the venous occlusion cuff in less than one heart beat.
The conclusions to be drawn from these tests are that the Al6 is equal to the predicate devices in accuracy and safety.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is facing to the left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2003
D.E. Hokanson, Inc. c/o Mr. D. Eugene Hokanson President 12840 NE 21st Place Bellevue. WA 98005
Re: K023707
Trade Name: Hokanson Blood Flow Measuring System Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: Class II (two) Product Code: JOM Dated: January 27, 2003 Received: February 4, 2003
Dear Mr. Hokanson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Mr. D. Eugene Hokanson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Olia Mallis
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Supplemental Information for A16 Blood Flow Measurement System, K023707
Intended Use Statement (modified)
The intended use of the Al6 is the measurement of blood flow by means of venous occlusion plethysmography. This is the same usage as one of the uses of our EC6 Plethysmograph and it has not changed.
Omallis
ivision of Cardiovascular Devices
510(k) Number K023707
Prescription Use X
(Per 21 CFR 801.109)
ltem 1